Clinical data management, CRO, biopharma, CLinical QA, Clinical QC

Quratul Ain

"ANNIE"

**** ************ ***, *********, ** 49006

Tel: 269-***-****

SUMMARY:

. Established successful interdisciplinary skills serving pharmaceutical,

biotech, health care and clinical research companies. Extensive work &

academic experience covering clinical study, database management,

clinical documentation, protocol enforcement, regulatory and quality

compliance.

1 EDUCATION:

. Bachelors of Science Biology The College of New Jersey. Ewing, New

Jersey-2012- GPA3.249

. Associates in Science Biology Mercer County Community College. East

Windsor, New Jersey.-2008-GPA3.23

.

2 SKILLS:

Chemistry applications including pH testing, weights and measurements

. Performing Pipetting and recording data. Basic knowledge of aseptic

techniques.

. Gram Stain positive and negative tests. Basic knowledge about the role

of microbes in industrial mechanisms.

. Strong computer, scientific, and organizational skills.

. Excellent communication (oral and written) and attention to detail.

Ability to work independently and as part of a team, self-motivation,

adaptability, and a positive attitude.

. Proficient in MS Office Suite (Word, Excel, Access, Outlook, Power

Point) email & voice mail), clinical supply experience, GCP, ICH, proven

successful quality assurance commitment, knowledge of FDA regulations,

Adobe, document management, proofreading skills, demonstrated analytical

& problem-solving skills, advanced medical terminology, workingly

knowledge of clinical drug development process, ability to follow SOPs

and regulatory guidelines, strong data Entry and tracking skills,

ability to analyze and implement solutions, ability to read, interpret

safety procedures and communicate effectively.

. Proven strong attention to detail, specially QC; excellent client

service focus; excellent communication, project management,

documentation, organizational & interpersonal skills.

. demonstrated ability to work successfully independently, & in a team

as well, & handle multiple deadline driven tasks in a dynamic fast-

paced environment.

3

4 EMPLOYMENT HISTORY:

Zoetis Pharmaceuticals:

August 2014 - Present

Kalamazoo, Michigan

Lead Data Entry Associate / Clinical Data Management

. Assists Zoetis Data Entry Lead in customer interactions, job scheduling,

job setup, job routing and oversight within Data Entry team and issue

resolution.

. Enter study data from paper data capture forms or on-line PDF renditions

of these forms into a VMRD (clinical) data management system.

. Visually verify data entered into the system (from a printed report)

against the original data records (entered by another data entry operator).

. Create data discrepancy worksheets based on problems found during the

processing of data entry requests.

. Log-out and/or update completed data processing requests in the

appropriate work tracking/forecasting systems and creating Batch Header

Sheet according to the Data Capture Forms (DCFs).

. Comply with all assigned SOPs and training requirements.

Covance Inc.

Sep 2012 - Sep 2013

Princeton, N.J.

Clinical Project Administrator / Clinical Development Services

. Promoting best documentation practice (QA for the documents) to line

functions to ensure that documents created/generated in the course of

clinical research are managed and archived in accordance with GCP

guidelines and Covance SOPs/business guidance documents.

. Scanning, indexing, reviewing clinical documents for quality

. Prepare documentation for GSS Associates and other materials for

delivery to archives.

. Set up and maintain clinical investigator files and documentation.

. Reaching out to sites, GSS managers, and GSS reviewers globally to

perform tasks for Site Contact Maintenance project.

. Process and track regulatory and investigator documents required for

study site activation in accordance with Covance SOPs, ICH GCP

guidelines and FDA regulations.

. Familiarity with ICH/GCP guidelines.

. Prepare investigator budget payments and tracking systems; generate

tracking reports.

. Data entry and maintenance of selected study tracking databases.

. Assisting regulatory affairs associates with sites inquiries and

regulatory documents.

. Action Decision Issue (ADI) logs for different studies portfolio

meetings focusing on startup activities as how to manage budget.

. Maintenance of allocated site's information in the Trial Tracker TM

Site Information Module study database as well as maintenance of

regulatory documents throughout the duration of the clinical trial.

. Understand and follow project specific and Covance policies and

procedures.

. Assemble administrative binders for study sites.

. Develop and populate response spreadsheets from returned surveys,

disseminate data to appropriate designees.

. Assume responsibility for contacting and following with Principal

Investigator and Regulatory contact (Globally) regarding completion of

Staff Contact Maintenance survey that may be required.

. Familiarity with investigator startup documents, working knowledge of

FDA, IRB/IEC and other applicable regulations/guidelines.

. Provide support to project team (e.g., word processing, proofreading

and editing correspondence, mailings, shipment of study files, fax and

photocopy documents, assemble study documents, and arrange meetings.

. Actively participating in process improvement for department

functions.

. Demonstrated consistently excellent knowledge of workload,

deliverables, and timelines.

. Trained and mentored entry-level CPA's on various project tasks to

ensure compliance.

5 Language Capabilities

. English

. Urdu

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